Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)

Summary

The purpose of the study is to compare early versus late initiation of enteral feeding in premature growth restricted babies below the gestational age of 35 weeks born to mothers with prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood flow from the mother to the baby brings all the nutrients required for growth and the very vital oxygen required for survival. These deprived babies with poor blood flow adapt to the not so conducive uterine environment by certain adjustments in blood supply to internal organs. This permits the best possible blood flow to brain heart etc., which are the vital organs and whose adequate functioning is required for survival. As a consequence, the gut (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized. Such 'premature growth restricted' babies are at increased risk of further growth faltering if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal distension, blood in stools and inability to feed for longer durations thereby further affecting growth. In the past such babies (after birth) were not fed for days together which compromised their growth even further. It is not clear whether continuing to withhold feeds for prolonged duration will prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with further compromised growth and increased morbidity. There are no randomized trials on feeding strategies in this group of neonates and hence the investigators planned to carry out this study on comparison of early versus delayed initiation of feeding in preterm SGA infants with AREDF.

Conditions

• Prematurity of Fetus
• Postnatal Growth Disorder

Interventions

OTHER

Early Feeding

Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life

OTHER

Late Feeding

Nil per oral for another 48 hrs after randomization at 60+/-12 hrs of life followed by Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs

Sponsors & Collaborators

• Sir Ganga Ram Hospital

  collaborator OTHER

• Maulana Azad Medical College

  collaborator OTHER

• Vardhman Mahavir Medical College And Safdarjung Hospital

  collaborator OTHER

• Fernandez Hospital

  collaborator UNKNOWN

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Dr Sushma Nangia, MBBS, MD · All India Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

48 Hours

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2008-01-31

Completion

2008-03-31

Countries

• India

Study Locations